Gilead has now also failed to protect its HIV blockbuster drug Truvada in Germany, in the Europe-wide dispute over its property rights. The German Federal Court of Justice declared its supplementary protection certificate void (case ID: X ZR 172/18). The decision is a severe economic setback for Gilead.
Gilead fought until the end for the economically-important property rights to Truvada. The dispute has already been unsuccessful in several other European countries. In 2018, the Court of Justice of the European Union ruling signalled the climax of the dispute over the combination of active ingredients.
HIV drug Truvada combines active ingredients tenofovirdisoproxil and emtricitabine. The basic patent EP 0 915 894 B1 expired in July 2017 and covers only tenofovirdisoproxil. The SPC was valid until August 2020 and protects the combination of both ingredients.
Several generic companies launched invalidity proceedings against the SPC for Truvada in different countries. This is because the 1997 application for the basic patent made no explicit reference to emtricitabine as an effective treatment for HIV.
Rohnke Winter (Karlsruhe) Christian Rohnke (BGH)
Cohausz & Florack (Düsseldorf): Arwed Burrichter, Natalie Kirchhofer, Romina Kühnle (all patent attorneys)
Hoyng ROKH Monegier (Düsseldorf): Christine Kanz, Thomas Misgaiski
In-house (Southall): Gavin Lawson (executive director IP)
df-mp Dörries Frank-Molnia & Pohlman (Munich): Ulrich Dörries, Simon Geiger (both patent attorneys)
In-house (London): Alpha Indraccolo (vice president and general counsel, European IP and regulatory litigation), Laura Reynolds (associate general counsel, European IP and regulatory litigation)
Ter Meer Steinmeister: Bernd Aechter, Markus Ackermann (both patent attorneys)
Taylor Wessing (Munich): Christoph de Coster (lead), Anja Lunze, Verena Bertram
In-house (Munich): Michael Rein
Isenbruck Bösl Hörschler (Munich): Ulrike Herr, Fritz Lahrtz (both patent attorneys)
Taylor Wessing (Munich): Dietrich Kamlah
In-house Lupin (Zug/Switzerland): Manish Mundra (associate director, IP), Nikhil Patil, Pavan Vitta
Federal Court of Justice, 10th Civil Senate, Karlsruhe
Klaus Bacher (presiding judge), Patrizia Rombach, Hermann Deichfuß, Hartmut Rensen, Helga Kober-Dehm
The complete Juve-Patent article can be downloaded under:https://www.juve-patent.com/news-and-stories/cases/federal-court-of-justice-destroys-spc-for-gilead-blockbuster-drug-truvada/